Modi 2016b.
Study characteristics | ||
Methods |
Study design: pilot RCT Method of randomisation: permuted block randomisation with block size 2 Setting: new‐onset seizure clinic in a Midwestern children's hospital Date it was conducted: January 2011‐October 2012 Source of funding: National Institutes of Health Conflict of interest: the study authors declare no conflict of interest |
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Participants |
Inclusion/exclusion criteria: patients with recent diagnosis of epilepsy (within 7 months), aged 2–12 years, no comorbid chronic illnesses requiring routine medications (e.g., diabetes), AED medication in pill or sprinkle form, family residing within 75 miles of the hospital, no significant parent‐reported developmental disorders (e.g. autism), and no prior AED treatment. Children with major developmental disorders were excluded. Sample size: 50 families. STAR intervention (n = 11) versus TAU (n = 12). Families with high adherence at baseline (n = 22) were not randomised. Of those randomised to the STAR intervention, 2 withdrew prior to treatment initiation and 1 family completed the intervention sessions but was lost to follow‐up. Age: 7.6 years (SD 3.0) Gender: 66.0% male |
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Interventions |
Type of intervention: educational Participants involved in 4 face‐to‐face sessions and 2 telephone problem‐solving sessions over 8 weeks Session 1 addressed deficit in epilepsy knowledge and provided feedback on each family AED adherence over the last 2 weeks. Sessions 2 through 4 aimed to teach families a problem‐solving approach for their identified AED‐adherence barriers. |
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Outcomes |
Primary outcome: adherence Secondary outcomes: epilepsy knowledge; medication self‐management; problem‐solving skills |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | permuted block randomisation with block size 2 |
Allocation concealment (selection bias) | Unclear risk | No information on concealment was reported |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No information on blinding was reported |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information on blinding was reported |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Of those randomised to the STAR intervention, 2 withdrew prior to treatment initiation and 1 family completed the intervention sessions but was lost to follow‐up. |
Selective reporting (reporting bias) | Unclear risk | Insufficient information to permit judgement |
Other bias | Unclear risk | Insufficient rationale or evidence to permit judgement |